The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Xp Knee System.
Device ID | K122160 |
510k Number | K122160 |
Device Name: | VANGUARD XP KNEE SYSTEM |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Contact | Tracy Bickel Johnson |
Correspondent | Tracy Bickel Johnson BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Product Code | MBH |
Subsequent Product Code | JWH |
Subsequent Product Code | MBV |
Subsequent Product Code | OIY |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-20 |
Decision Date | 2013-03-20 |
Summary: | summary |